Scientist III, Injectable Drug Product Development
100 College St New Haven, CT 06510 US
This is what you will do:
In this role the candidate will lead cross-functional efforts in the research, design and execution of scientific studies to enable the drug product (DP) process development, characterization, and commercial validation of parenteral/injectable biologic products. The candidate will lead the development of a variety of manufacturing unit operations including, but not limited to, drug substance (DS) freeze/thaw, compounding/mixing, sterile filtration, drug product filling of vials/syringes, visual inspection, and DS/DP transportation. Hands on experience with biotherapeutics drug product development, including a detailed understanding of the manufacturing unit operations is required. An understanding of protein chemistry, formulation, and biopharmaceutical assay (e.g. HPLC, CE, iCE, HIAC, MFI, etc.) development as well as the ability to run biopharmaceutical assays in a laboratory is necessary.
The candidate will establish continuous improvement systems based on lessons learned and implement these improvements in areas of manufacturing technology transfer activities, including but not limited to sending/receiving site process gap analysis, process FMEAs (failure mode and effects analysis), change control owner/leader, master batch record review, as well as at-scale/full scale process development studies, protocols, and reports. Experience in supporting deviations, change controls, and CAPAs utilizing electronic Quality system such as Trackwise is also desirable.
In addition, the candidate will provide clinical and commercial manufacturing site support including but not limited to weekly/biweekly support meetings, action item owner, and as necessary in-person on-site manufacturing support. This position is expected to interact regularly with cross-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs.
You will be responsible for:
- Leads drug product development teams with multiple cross functional stakeholders, as well as understand the cross functional implication of project activities and decisions on project and corporate objectives. Makes scientific/technical proposals based on corporate or project objectives.
- The candidate must have the ability to communicate effectively with senior management, external partners, and/or regulatory agencies. Actively participates in department and team meetings including assuming ownership and delivering on assign action items.
- Understands "big pictures" for projects and tasks involved and prioritize work of self and others accordingly. Prioritizes multiple assigned tasks and projects and leads project teams consisting of one or more junior team members. The ability to work independently as well as part of the team is essential.
- Independently designs and executes development studies for Alexion pharmaceuticals’ drug candidates and commercial products, support tech transfer activities for internal manufacturing and contract manufacturing sites
- Performed in depth data analysis as well as authors technical reports and or relevant sections of clinical and commercial regulatory filings on the executed studies for the Alexion drug product candidates
- Be current with the literature about drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations
You will need to have:
- PhD in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 5+ years, a MS with 14+ years or BS with 15+ years of relevant experience. Solid background in protein chemistry, chemistry, biochemistry, or equivalent is highly preferred.
- Scientific and practical knowledge of protein biochemistry, protein formulation/stability, as well as biotherapeutic drug product process development is essential.
- Hands-on experience with defining processes, scale up, transferring information between development and manufacturing sites, document preparation
- Experience in biotherapeutics development as well as understanding of the biotechnology products life cycle
- Understanding of the biotherapeutics drug formulation development and analytical tools used to test formulations is a plus.
- Makes strategic scientific/technical proposals based upon corporate or project objectives and has the ability to take initiative in problem solving and finding solutions to scientific challenges.
- The individual must be able to work in a collaborative setting and ability to adhere to timelines is essential.
- Excellent interpersonal skills are required, as is the strong ability to communicate effectively, as well as mentor and motivate others within the department and as part of actively participating in cross-functional teams.
- The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging
We would prefer for you to have:
- Experience with electronic record keeping and data software, like electronic lab notebooks, EndNote, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, Visio, JMP/Minitab, and Adobe Pro, would be an advantage.
- Knowledgeable in Global Regulatory guidances, cGMPs, and Quality/Compliance expectations for the development of parenterals
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